The present disclosure relates generally to medical fluid handling and in particular to the packaging and sterilization of medical fluid bags or containers.
It is known to package a sterile medical fluid, such as dialysis fluid, in medical fluid bags. The bags in many instances are provided with tubing preconnected to the bags. This tubing needs to be sterilized. One method of sterilization is steam sterilization. Steam sterilization is advantageous over other forms of sterilization, such as ethylene oxide (“EtO”) sterilization, which requires the application of a vaporized chemical, and gamma radiation, which can leave an odor and/or discolor the sterilized item.
One requirement for steam sterilization however is that the surface to be sterilized must be adequately contacted by the steam. Failure to do so will result in an improperly sterilized item.
The bag tubing set is often provided with one or more external clamps, such as a Roberts™ clamp. For various reasons, the external clamps may become partially or fully closed or clamped, for example, during shipping or during the sterilization process itself. It is desirable to pre-attach the external clamps prior to shipping and sterilization, creating the need for an apparatus and method to prevent the external clamps from becoming inadvertently locked or closed prior to sterilization.